MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84592
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the outer shaft fractured.A direxion fathom-16 system was selected for an embolization procedure in the moderately tortuous vessel to treat bleeding.During the procedure while attempting to torque the device, the outer nickel shaft fractured and came loose from the inner shaft inside the patient.The device was removed from the patient and the procedure was successfully completed with a new direxion fathom-16 system.There were no patient complications reported.
Event or Problem Description
It was reported the outer shaft fractured.A direxion fathom-16 system was selected for an embolization procedure in the moderately tortuous vessel to treat bleeding.During the procedure while attempting to torque the device, the outer nickel shaft fractured and came loose from the inner shaft inside the patient.The device was removed from the patient and the procedure was successfully completed with a new direxion fathom-16 system.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval by mfr: the returned direxion microcatheter was analyzed for any damage.The devices shaft showed damage in the form a distal shaft fracture.The fracture was located 4cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11280684
• Report Number: 2134265-2021-01284
• Device Sequence Number: 14125515
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0025976287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1